Radiosurgery With or Without Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
A Phase III Randomized Trial Of The Role Of Whole Brain Radiation Therapy In Addition To Radiosurgery In The Management Of Patients With One To Three Cerebral Metastases
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiosurgery may be able to deliver x-rays directly to the tumor and cause less damage to normal tissue. It is not yet known if radiosurgery is more effective with or without whole-brain radiation therapy in treating brain metastases.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiosurgery with or without whole-brain radiation therapy in treating patients who have brain metastases.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
OBJECTIVES:
- Compare the overall survival of patients with 1 to 3 cerebral metastases treated with radiosurgery with or without whole brain radiotherapy.
- Compare the time to CNS failure (brain) in patients treated with these regimens.
- Compare the quality of life, duration of functional independence, and long-term neurocognitive status in patients treated with these regimens.
- Compare the post-treatment toxic effects of these regimens in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (60 and over vs under 60), extracranial disease (controlled for more than 3 months vs controlled for 3 months or less), and number of brain metastases (1 vs more than 1). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo radiosurgery.
- Arm II: Patients undergo radiosurgery. Within 14 days, patients then undergo whole brain radiotherapy 5 days a week for 2.5 weeks.
Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years.
Patients are followed at weeks 6 and 12, every 3 months for 9 months, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 480 patients (240 per treatment arm) will be accrued for this study within 5 years.
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
-
-
Alabama
-
Birmingham, Alabama, Estados Unidos, 35294-3295
- University of Alabama at Birmingham Comprehensive Cancer Center
-
-
Arizona
-
Phoenix, Arizona, Estados Unidos, 85013
- Foundation for Cancer Research and Education
-
Phoenix, Arizona, Estados Unidos, 85001-2071
- St. Joseph's Hospital and Medical Center
-
-
California
-
Concord, California, Estados Unidos, 94524-4110
- Mount Diablo Regional Cancer Center
-
Sacramento, California, Estados Unidos, 95816
- Sutter Cancer Center
-
San Francisco, California, Estados Unidos, 94115
- UCSF Comprehensive Cancer Center
-
Walnut Creek, California, Estados Unidos, 94598
- John Muir Comprehensive Cancer Center at John Muir Medical Center
-
-
Colorado
-
Aurora, Colorado, Estados Unidos, 80010
- University of Colorado Cancer Center at University of Colorado Health Sciences Center
-
-
Connecticut
-
New Haven, Connecticut, Estados Unidos, 06520-8040
- Yale Comprehensive Cancer Center
-
-
Florida
-
Gainesville, Florida, Estados Unidos, 32610-100277
- Shands Cancer Center at the University of Florida Health Science Center
-
-
Illinois
-
Chicago, Illinois, Estados Unidos, 60612
- University of Illinois Medical Center
-
-
Iowa
-
Davenport, Iowa, Estados Unidos, 52803
- Genesis Regional Cancer Center at Genesis Medical Center
-
-
Kansas
-
Kansas City, Kansas, Estados Unidos, 66160-7357
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
-
-
Maryland
-
Baltimore, Maryland, Estados Unidos, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02115
- Brigham and Women's Hospital
-
-
Michigan
-
Detroit, Michigan, Estados Unidos, 48201-1379
- Barbara Ann Karmanos Cancer Institute
-
Detroit, Michigan, Estados Unidos, 48202
- Josephine Ford Cancer Center at Henry Ford Health System
-
-
Missouri
-
Saint Louis, Missouri, Estados Unidos, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital
-
-
New Jersey
-
Edison, New Jersey, Estados Unidos, 08818
- John F. Kennedy Medical Center
-
-
New York
-
Syracuse, New York, Estados Unidos, 13210
- SUNY Upstate Medical University Hospital
-
-
North Carolina
-
Charlotte, North Carolina, Estados Unidos, 28232-2861
- Blumenthal Cancer Center at Carolinas Medical Center
-
Charlotte, North Carolina, Estados Unidos, 28232-2861
- Carolina Neurosurgery and Spine Associates
-
Durham, North Carolina, Estados Unidos, 27710
- Duke Comprehensive Cancer Center
-
Durham, North Carolina, Estados Unidos, 27705
- American College of Surgeons Oncology Group
-
Winston-Salem, North Carolina, Estados Unidos, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
-
-
Ohio
-
Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic Taussig Cancer Center
-
-
Pennsylvania
-
Hershey, Pennsylvania, Estados Unidos, 17033-0850
- Penn State Cancer Institute at Milton S. Hershey Medical Center
-
Pittsburgh, Pennsylvania, Estados Unidos, 15213
- University of Pittsburgh Medical Center
-
Pittsburgh, Pennsylvania, Estados Unidos, 15212-4772
- Allegheny General Hospital
-
Pittsburgh, Pennsylvania, Estados Unidos, 15215
- UPMC St. Margaret
-
Pittsburgh, Pennsylvania, Estados Unidos, 15213-2582
- University of Pittsburgh Medical Center - Shadyside Hospital
-
-
Tennessee
-
Memphis, Tennessee, Estados Unidos, 38104
- Methodist Cancer Center at Methodist University Hospital
-
-
Utah
-
American Fork, Utah, Estados Unidos, 84003
- American Fork Hospital
-
-
Virginia
-
Charlottesville, Virginia, Estados Unidos, 22908
- Cancer Center at the University of Virginia
-
Richmond, Virginia, Estados Unidos, 23298-0631
- Massey Cancer Center at Virginia Commonwealth University
-
-
Wisconsin
-
Madison, Wisconsin, Estados Unidos, 53792-7375
- University of Wisconsin Comprehensive Cancer Center
-
Milwaukee, Wisconsin, Estados Unidos, 53226
- Medical College of Wisconsin Cancer Center
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
Diagnosis of cerebral metastases meeting all of the following requirements:
- 1-3 de novo lesions
- Metastases must be from a histologically confirmed extracerebral primary site, another metastatic site, or from the metastatic brain lesion(s)
- Each lesion must be less than 3.0 cm by contrasted MRI of the brain
- Lesions must not be within 5 mm of optic chiasm or within the brainstem
- No primary germ cell tumor, small cell carcinoma, or lymphoma
- No leptomeningeal metastases
- Eligible for treatment with gamma knife or linear accelerator-based radiosurgery
- Performance status - ECOG 0-2
- Performance status - Zubrod 0-2
- Not pregnant
- Negative pregnancy test
Fertile patients must use effective contraception
* Male patients must continue to use contraception for 3 months after the completion of radiotherapy
- No pacemaker or other MRI-incompatible metal in body
- No known allergy to gadolinium
- Deemed to be at low risk for recurrence from any prior malignancies
- At least 7 days since prior chemotherapy
- Concurrent hormonal agents allowed
- Concurrent steroids allowed
- No prior cranial radiotherapy
- No prior resection of cerebral metastasis
- Concurrent anticonvulsants allowed provided therapeutic serum/plasma level maintained before study intervention
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: radiosurgery
Patients undergo radiosurgery. Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years. |
|
|
Experimental: radiosurgery + WBRT
Patients undergo radiosurgery. Within 14 days, patients then undergo whole brain radiotherapy 5 days a week for 2.5 weeks. Quality of life is assessed at baseline, the beginning of each treatment, at week 6, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 2 years. Patients are followed at weeks 6 and 12, every 3 months for 9 months, every 4 months for 1 year, every 6 months for 2 years, and then annually thereafter. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Overall survival (OS)
Prazo: Up to 6 months
|
Up to 6 months
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Time to CNS failure
Prazo: Up to 4 years
|
Up to 4 years
|
|
Change in QOL between SRS and SRS + WBRT treatment groups using the FACT-BR questionnaire
Prazo: From baseline to up to 3 months
|
From baseline to up to 3 months
|
|
Change in the duration of functional independence using the Barthel ADL Index score
Prazo: From baseline to up to 4 years
|
From baseline to up to 4 years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: Anthony Asher, MD, FACS, Carolina Neurosurgery and Spine Associates
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ACOSOG-Z0300
- CDR0000069183 (Outro identificador: NCI Physician Data Query)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .